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Alzheimer’s Research Announced in New London

Thursday, October 8th, 2020

New LUCIDITY clinical study to investigate potential treatment for people with Alzheimer’s disease

New London, October 2020- Coastal Connecticut Research has announced the start of patient recruitment for the LUCIDITY study (NCT03446001), a new clinical research study to evaluate an investigational drug in people who are experiencing memory loss, or have been diagnosed with Mild Cognitive Impairment (MCI or MCI-AD), Probable/Early Alzheimer’s disease (AD) or Mild-Moderate AD.

Dr. Laurence Radin will be serving as Principal Investigator of the study. He has served as the study doctor on over 10 clinical research trials for Alzheimer’s disease at Coastal Connecticut Research supported by a team of sub-investigators.

Although it is often accepted that some degree of forgetfulness is a natural part of the aging process, more severe memory loss – especially that which impacts daily life – could be an early sign of AD. Up to one third of people with MCI will go on to develop dementia,1 which affects around 50 million people worldwide.2

Currently, a limited number of approved treatments help with the symptoms of AD, but do not stop the disease from progressing.3 There are many factors and underlying challenges that contribute to the difficulty of developing new treatment options.3 However, rapid advances in our understanding of the underlying causes and risk factors associated with AD have led to new therapeutic targets and approaches.

Recent evidence suggests that Tau tangles are a potential driver in the progressive dementia that characterizes AD .4,5 Tau is a protein that forms part of a brain cell’s structure called a ‘microtubule.’ The microtubule helps transport nutrients within the brain cell and stabilizes the axons (a portion of a nerve cell) that connect one brain cell to another. In people with AD, Tau proteins do not function properly and form tangles inside the brain cells. This leads to a breakdown in the brain cell’s ability to communicate with other brain cells, which causes the symptoms of AD.6

Following nearly 30 years of research, researchers believe that a second-generation Tau aggregation inhibitor (TAI) could reduce the build-up of Tau tangles, and in doing so, could help slow disease progression and enhance quality of life for people with AD. Previous Phase 3 clinical trials (NCT01689233 and NCT01689246) support the possibility that this investigational treatment could be effective as a monotherapy, at a dose as low as 4 mg twice daily.7,8

Principal Investigator Dr. Laurence Radin said: “It is crucial we continue to research new targets and treatment options for Alzheimer’s disease. We are pleased to support the roll-out of the LUCIDITY study in Southeastern Connecticut, of which the results have the potential to provide renewed hope for the many people affected by this devastating disease.”

The LUCIDITY study, sponsored by TauRx Therapeutics Ltd. (“TauRx”), will evaluate the effects of this treatment in slowing or delaying memory loss in people who are not receiving other approved treatments for AD (cholinesterase inhibitors and/or memantine). Approximately 450 people in more than 100 study centers across North America and Europe are expected to take part in this study. The results of the study will help determine whether the investigational drug should progress to the final stages of clinical development.

Professor Claude Wischik, Executive Chairman and Co-Founder of TauRx, comments: “With no current cure and an aging population, Alzheimer’s disease is a pressing societal concern and there is an urgent need for new solutions. Our drug, an oral second-generation TAI, has already demonstrated encouraging signals in terms of efficacy and safety in previous trials, to the extent that it warrants further investigation. It’s our aim to find innovative and lasting solutions for patients living with Alzheimer’s disease, and we believe that Tau aggregation inhibition could be part of that solution.”

To learn more about the LUCIDITY study and to find out if you are eligible to participate, visit the trial website: LUCIDITYtrial.com or call Coastal Connecticut Research at (860)443-4567.  Information is also available at ccrstudies.com.

About Alzheimer’s disease

Alzheimer’s disease (AD) is a progressive neurologic disease of the brain that causes damage to neurons – the specialized cells of the nervous system that enable the flow of information, thoughts and memories in the brain. When Alzheimer’s damages neurons it leads to loss of memory and reasoning, which can affect a person’s ability to interact socially or function at work. No treatment yet exists to halt the progression of Alzheimer’s-related dementia, delay its onset, or prevent it from occurring. Currently available drugs only treat the symptoms temporarily.

Tau aggregation inhibitors

TauRx’s Tau aggregation inhibitors (TAIs) have arisen from nearly 30 years of research, preclinical and clinical investigations. TAIs work by undoing the Tau tangles that cause dementia, thereby potentially slowing and even arresting memory loss. The first-generation TAI, rember® was a patented, highly-purified version of methylthioninium chloride (methylene blue), a compound previously used to treat a variety of conditions.

About the LUCIDITY Study

LUCIDITY is a two-phase outpatient study with Phase 1 being a randomized, double-blind, placebo-controlled, 3-arm, 52-week safety and efficacy study and Phase 2 being an open-label, delayed start study, of an investigational drug in patients with Mild Cognitive Impairment (MCI or MCI-AD), or Probable/Early or Mild-Moderate Alzheimer’s disease. The primary objective of the LUCIDITY study is to demonstrate that the investigational treatment, given as a monotherapy at doses of 8 mg/day and 16mg/day, is effective compared to placebo in delaying the pathological and clinical progression of the disease. This will be measured using standard clinical cognitive and functional assessments; the study is expected to last up to 120 weeks for individual participants. LUCIDITY is now recruiting in sites across the United States, Canada, UK, France, Belgium, Italy, Spain and Poland. For further information, please visit: www.LUCIDITYtrial.com.

About Site

Coastal Connecticut Research in New London has partnered with community volunteers for over 20 years in conducting healthcare clinical research.  The site was founded by Dr. Robert M. Spitz who also serves as Medical Director.  In their two-decade history, 20 medications evaluated by community volunteers have gained FDA approval.

References

  1. Mavrodaris A, et al. Prevalences of dementia and cognitive impairment among older people in sub-Saharan Africa: a systematic review. Bull World Health Organ 2013, 91:773–783.
  2. World Health Organization. 2016 Dementia Fact Sheet. Available at: http://www.who.int/mediacentre/factsheets/fs362/en/ Accessed February 2019.
  3. Alzheimer’s Association. 2018 Alzheimer’s Disease Facts and Figures. Available at: https://alz.org/media/HomeOffice/Facts%20and%20Figures/facts-and-figures.pdf Accessed February 2019.
  4. Simić G, et al. Tau protein hyperphosphorylation and aggregation in Alzheimer’s disease and other tauopathies, and possible neuroprotective strategies. Biomolecules 2016, 6(1):6.
  5. Iqbal K, et al. Tau pathology in Alzheimer disease and other tauopathies. Biochim Biophys 2005, 1739(2-3):198–210.
  6. National Institute of Ageing. 2008 Alzheimer’s disease: Unravelling the mystery. Available at: https://adrccares.org/wp-content/uploads/2016/01/alzheimers_disease_unraveling_the_mystery_0.pdf Accessed February 2019.
  7. Gauthier S, et al. Efficacy and safety of tau-aggregation inhibitor therapy in patients with mild or moderate Alzheimer’s disease: a randomised, controlled, double-blind, parallel-arm, phase 3 trial. The Lancet 2016, 388:2873-84.
  8. Wilcock GK, et al. Potential of Low Dose Leuco-Methylthioninium Bis (Hydromethanesulphonate) (LMTM) Monotherapy for Treatment of Mild Alzheimer’s Disease: Cohort Analysis as Modified Primary Outcome in a Phase III Clinical Trial. Journal of Alzheimer’s Disease 2017, 61:435-457.

Media contacts:

MaryLou Gannotti

Email: marylou@ccrstudies.com

Call: (860)437-7092

Visit online: www.CCRstudies.com

LUCIDITY study website: LUCIDITYtrial.com

TauRx website: http://www.taurx.com

 

Giving Thanks for You!

Wednesday, November 16th, 2016

This Thanksgiving season, Coastal Connecticut Research would like to remind all of our volunteers how thankful we are for you!

Research volunteers make a difference in the lives of others and in shaping treatments for a variety of conditions. There are times a research volunteer might participate in the study of an investigational medicine, and there are times a volunteer might participate in a research study involving an FDA-approved medication in a new formulation.  Here at CCRstudies, research volunteers have tested devices as well and participated in observational studies, where there is no medication involved.

Research volunteers come from all walks of life.  Those who enter our research studies represent a diverse population.  What these volunteers have in common is a desire to help others by participating in research.

So, as we gather at the table with family and friends this Thanksgiving, we would like to acknowledge all those who help to make a difference in the world.  Thank you volunteers!  You are truly “medical heroes!”

Contact Coastal Connecticut Research at (860)443-4567 or email marylou@ccrstudies.com if you wish to join our special group of volunteers!

C’mon Down! Research Volunteers Needed!

Thursday, October 13th, 2016

nurses1

Research volunteers are needed in Southeastern Connecticut.  Coastal Connecticut Research, located on Montauk Avenue in  New London,  seeks people from all backgrounds and all walks of life to participate in clinical research studies.

Our Certified Research Coordinators and Study Nurses Jessie Jellison Hatfield, LPN, Diane Palmer, RN and Beth Rogers, LPN are available to answer any questions you might have regarding your role in research.  Board-Certified physicians serve as the principal investigators on our studies, which include trials in women’s healthcare, neurology, and internal medicine.

You don’t have to be living with a major illness to participate in research. Healthy volunteers are currently needed for studies on conditions such as postmenopausal vaginal dryness,  urinary incontinence, and memory loss.  If you are someone who would like to take an active role in the future of healthcare and the development of medicines to treat individuals in the US and beyond, please consider becoming a research volunteer.  There is no cost to participate, no cost for study-related products and no insurance is needed.

Talk to a friendly and informative member of our team today.  Call (860)443-4567 or email marylou@ccrstudies.com  We look forward to hearing from you.